Millipore Millex-FG User manual

User Guide
Millex®-FG
Hydrophobic Filter Unit
■ Single use only
■ Sterile
■ Non-pyrogenic
■ Do not use this product as an in-line filter for intravenous administration
SLFG M25 LS (50/box)

Notice
The information in this document is subject to change without notice and should not
be construed as a commitment by Millipore Corporation. Millipore Corporation as-
sumes no responsibility for any errors that may appear in this document. This manual
is believed to be complete and accurate at the time of publication. In no event shall
Millipore Corporation be liable for incidental or consequential damage in connection
with or arising from the use of this manual.
Copyright 2005, Millipore Corporation. All rights reserved. Printed in Ireland.
Millipore and Millex are registered trademarks of Millipore Corporation.
Fluoropore is a trademark of Millipore Corporation.
Freon is a trademark of E. I. du Pont de Nemours & Co., Inc.
Luer-Lok is a trademark of Becton, Dickinson and Company.
PR01663, Rev. A, 11/05
This product is manufactured by:
Millipore Ireland BV,
Carrigtwohill,
Co. Cork

Introduction
The bi-directionally supported Millex-FG filter unit is a sterilizing filter for gases and
liquids that are not compatible with standard membrane filters. It will remove microor-
ganisms, particles, precipitates, and undissolved powders larger than 0.2 micron (µm).
The sterile Millex-FG filter unit is non-pyrogenic and non-toxic. This single-use product
consists of a 0.2 µm, hydrophobic Fluoropore™ membrane filter sealed in a PVC hous-
ing. Typical applications include the sterile filtration of alcohols, concentrated acids and
bases, and air or gas.

Chemical Compatibility
The Millex-FG filter unit is compatible with most aqueous solutions. It may be used to
filter the agents listed below. This guide has been developed from technical publica-
tions, materials suppliers, laboratory tests, and field evaluations, etc., and is believed to
be reliable. However, because of variability in temperature, concentrations, duration of
exposure, and other factors outside of our control which may affect the use of the unit,
no warranty is given or is to be implied with respect to such information. Agents not
listed below should be tested with the Millex-FG filter unit prior to use.
Chemical
2www.millipore.com/sterile
Acetic acid (glacial)
Acetic acid (5%)
Aliphatic ethers
Ammonium hydroxide (6N)
Amyl alcohol
Benzyl alcohol (1%)
Boric acid
Brine (sea water)
Butyl alcohol
Ethyl alcohol
Ethylene glycol
Formaldehyde
Freon®solvent, TF or PCA
Glycerine (glycerol)
Helium
Hexane
Hydrochloric acid (conc.)
Hydrofluoric acid
Hydrogen (gas)
Hydrogen peroxide (3%)
Hypo (photo)
Isobutyl alcohol
Isopropyl alcohol
Kerosene
Methyl alcohol
Mineral spirits
Nitrogen
Paraldehyde
Pet base oils
Pentane
Petroleum ether
Phenol (0.5%)
Pyridine
Silicone oils
Sodium hydroxide
TFA

How to Use the Millex-FG Filter Unit
This section lists warnings and cautions and provides steps to use the Millex-FG Filter Unit.
WARNINGS:
■To ensure sterility, do not use this product if the package is damaged.
■Do not use this product as an in-line filter for intravenous administration; it
was not designed for that purpose.
■Do not use with syringes smaller than 10 cc because pressures in excess of
the maximum pressure rating may be reached, potentially causing damage to
the filter unit and/or personal injury.
CAUTIONS:
■Do not resterilize or reuse the Millex-FG filter unit.
■Do not use the Millex-FG unit at temperatures above 45 °C (113 °F).
■Do not use the same Millex-FG filter unit to filter solutions in both directions.
■Do not use the Millex-FG filter unit to filter emulsions or suspensions.
■Do not use the Millex-FG filter unit to filter 5 mg or less of active drug materials
unless binding studies have been performed.
■When used to protect a vacuum system, the Millex-FG unit may become momen-
tarily inoperable if aqueous fluid completely fills the housing. To clear the unit,
disconnect it from the upstream Luer connection and aseptically apply air pressure
with a syringe.
Millex-FG Hydrophobic Filter Unit 3

4www.millipore.com/sterile
Directions for the Millex-FG Filter Unit
Hold the syringe with the filter (and needle if
attached) pointing up and top it off by pushing
a few drops through it. (Make sure you do not
contaminate the underside of the Millex-FG
filter unit with your fingers.)
Insert the needle (if attached) and push the
plunger to deliver the filtered solution.
NOTE: When filtering aqueous solutions (acids,
bases), filter 10 mL of ethanol or methanol
through the unit to wet the hydrophobic filter.
Then, discard the first 2–3 mL of filtered solution
to prevent alcohol contamination.
23 1
45
Fill the syringe with the solu-
tion to be filtered.
NOTE: If you are using the
filter unit with a vacuum or air
system, attach the appropriate
Luer adapters to the vacuum or
air system tubing.
Aseptically remove the cover
from the package that contains
the Millex-FG filter unit.
Attach the syringe to the Millex-
FG filter unit and remove the
assembly from the package.
(Attach needle to Luer Slip out-
let if necessary.)

Millex-FG Hydrophobic Filter Unit 5
Technical Assistance
For more information, contact the Millipore office nearest you. In the U.S., call 1-800-
MILLIPORE (1-800-645-5476). Outside the U.S., see your Millipore catalogue for the
phone number of the office nearest you or go to our web site at www.millipore.com/
offices for up-to-date worldwide contact information. You can also visit the tech service
page on our web site at www.millipore.com/techservice.
Specifications
Materials Fluoropore PTFE membrane, type FG; PVC housing
Dimensions inlet to outlet 25 mm (1 in.)
diameter 29 mm (1.13 in.)
filtration area 4 cm2(0.62 in.2)
pore size 0.2 µm
Temperature limit 45 °C (113 °F) maximum
Pressure limit at 25 °C 75 psig inlet and differential maximum
Filtration volume 1 mL to 100 mL
Hold-up volume ≤0.1 mL after air purge
Connections female, Luer-Lok®inlet; male, Luer-slip outlet

Standard Warranty
Millipore Corporation (“Millipore”) warrants its products will meet their applicable
published specifications when used in accordance with their applicable instructions for a
period of one year from shipment of the products. MILLIPORE MAKES NO OTHER
WARRANTY, EXPRESSED OR IMPLIED. THERE IS NO WARRANTY OF MERCHANT-
ABILITY OR FITNESS FOR A PARTICULAR PURPOSE. The warranty provided herein
and the data, specifications and descriptions of Millipore products appearing in
Millipore's published catalogues and product literature may not be altered except by
express written agreement signed by an officer of Millipore. Representations, oral or
written, which are inconsistent with this warranty or such publications are not authorized
and if given, should not be relied upon.
In the event of a breach of the foregoing warranty, Millipore's sole obligation shall be to
repair or replace, at its option, the applicable product or part thereof, provided the cus-
tomer notifies Millipore promptly of any such breach. If after exercising reasonable ef-
forts, Millipore is unable to repair or replace the product or part, then Millipore shall
refund to the customer all monies paid for such applicable product or part. MILLIPORE
SHALL NOT BE LIABLE FOR CONSEQUENTIAL, INCIDENTAL, SPECIAL OR ANY
OTHER DAMAGES RESULTING FROM ECONOMIC LOSS OR PROPERTY DAMAGE
SUSTAINED BY ANY CUSTOMER FROM THE USE OF ITS PRODUCTS.